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The Food and Drug Administration (FDA) notifies the public on the WHO Medical Product Alert on falsified (contaminated) Propylene Glycol USP/EP which were detected in Eastern Mediterranean region between January to March 2024:

PRODUCT NAME (1) Dow USP/EP Propylene Glycol
STATED MANUFACTURER Dow Chemical, Thailand Ltd.
BATCH NO. C815N3OR41 C856H85R55
MFG. DATE 03-23 2023 01 15
EXP. DATE 03-25 2023 01 15
IDENTIFIED IN Pakistan
PRODUCT NAME (2) Dow USP/EP Propylene Glycol Propylene Glycol USP/EP
STATED MANUFACTURER Dow Chemical Pacific (Singapore) Private Limited Dow Europe, GmbH, Germany
BATCH NO. C815L44R41 C8115L44R52 F8900L8PPD6
MFG. DATE Not reported Feb 2023
EXP. DATE Not reported Feb 2025
IDENTIFIED IN Pakistan

 

 

 

 

 

 

 

 

 

 

 

 

 

The FDA strongly advises the drug manufacturers, traders, distributors and concerned stakeholders to be vigilant on the circulation of these falsified excipient since its contaminants, Diethylene Glycol and Ethylene Glycol, are toxic to humans when consumed above the acceptable limit and may result to abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death. Falsified drug products are products that are deliberately/fraudulently misrepresent their identity, composition or source.

This is to emphasize that the abovementioned raw material is used as an excipient in pharmaceutical and other manufacturing processes for medicinal use. However, it is important to detect and remove this raw material from circulation to prevent harm to patients.

Therefore, all Local Government Units (LGU) and Law Enforcement Agencies (LEAs), after the issuance of this advisory, are requested to ensure that this falsified raw material is not used for manufacturing of drug products in their localities or areas of jurisdiction. Furthermore, manufacturers of liquid dosage forms, especially syrups that contain excipients such as propylene glycol, polyethylene glycol, sorbitol, and/or glycerin/glycerol, are urged to test for the presence of the stated contaminants before use in production of pharmaceutical products.

For more information and inquiries, please e-mail us at cdrr_postmarketsurveillance@fda.gov.ph. To report unauthorized sale, or distribution of the abovementioned, kindly e-mail us via cdrr.od@fda.gov.ph. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596.

Dissemination of the information to all concerned is highly requested.

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